Surgical procedures, known as ostomies, are some times necessitated due to inflammatory bowel disease, cancer, or injury. An ostomy creates an artificial opening (stoma) in the abdomen for the elimination of bodily waste. Since the ostomy patients are unable to control the passage of bodily waste material, use is made of an appliance attached to the body to collect this material. Conventional available ostomy appliances consist of a pouch, made up of a barrier plastic material, attached to a hydrocolloid containing synthetic rubber based adhesive gasket capable of adhering to the skin around the stoma. The adhesive gasket is capable of anchoring the appliance to the skin for time periods ranging from one day to as long as 10 days. The adhesive gasket does protect the peristomal skin. However, it is very difficult for the ostomate to cut a hole in the wafer to fit perfectly around the stoma to achieve a fluid proof seal between the stomal opening of the gasket and the stoma. Therefore, some areas of the peristomal skin may remain exposed and become vulnerable to the deleterious effects of the intestinal effluents, which can cause serious irritation, excoriation, and eventual breakdown of the skin contiguous to the stoma. In addition, the fluid leakage may also cause disintegration of the gasket, resulting in breach of its barrier properties and exacerbating the problem of skin protection. Another frequent cause of peristomal skin complications is stomal effluent undermining a skin barrier due to irregularities in stoma placement, stoma shape, retraction or scarring. When peristomal surface unevenness is severe, the appliance gasket may fail to achieve an acceptable seal resulting in undermining of the gasket by the stomal effluent, causing leakage, discomfort and pain.
For these reasons, many ostomates use one of the additional means available in the form of pastes, hydrocolloid powders, karaya seal rings, skin barrier rings, or adhesive strips to augment the sealing function of the gasket. Some of the commercially available paste products include those under trade names Stomahesive.TM. Paste (ConvaTec, Bristol-Myers Squibb), Proshield Plus (Health Point), Hollihesive Paste (Hollister Incorporated), Coloplast Ostomy Paste (Coloplast Sween Corporation), and Dansac Soft Paste (Incutech Inc.). One of the disadvantages of such pastes is that some of them contain solvents, which are irritating to skin. The other disadvantage is that the pastes are easily subject to disintegration upon fluid absorption. Therefore, their protective effect is not long lasting.
U.S. Pat. No. 4,204,540 describes a composition adapted for use around the stoma and consisting of a homogeneous mixture of a pressure-sensitive adhesive component, mineral oil, and hydrocolloid gums or cohesive strengthening agents or a mixture of hydrocolloid gums and cohesive strengthening agents. A balance of different components in the mixture provides compositions which can be shaped by hand to seal the skin surface between the gasket and the stoma.
U.S. Pat. No. 4,231,369 describes a gel like sealant composition composed of a physical mixture of tackified styrene-olefin-styrene block copolymer having at least one hydrocolloid dispersed therein.
U.S. Pat. No. 4,350,785 describes an ostomy paste formulated as mixtures of water absorbing particulate hydrocolloid gums and organic solvent (e.g. alcohol) solutions of adhesive film forming resins, such as poly(methyl vinyl ether/maleic acid), having increased resistance to urine and intestinal fluids by incorporating a small amount of colloidal silica, preferably fumed silica.
U.S. Pat. No. 4,578,065 describes protective sealing compositions in the form of molded rings or sheets, which comprise gelled mixtures of water absorbing particulate hydrocolloid gum and non-toxic polyhydroxyalcohol, having increased resistance to the drained fluid (e.g. urine or intestinal fluids) by incorporating a small amount of fumed silica or colloidal silica gel.
U.S. Pat. No. 4,477,325 to Osburn decribes sealant or paste composition of hydrocolloids in a network of an elastomeric copolymer of ethylene and vinyl acetate, and polyisobutylene; the mechanical strength and fluid endurance of which is enhanced by crosslinking, produced by irrradiating the mixture.
U.S. Patent No. 4,738,257 to Meyer et al describes a continuous elastomeric phase, formed by cross-linking to form a network, and distinguishes itself by stating that in Sorensen and Osburn, above, that after absorbing enough water, the hydrocolloid loses its wet tack, or ability to adhere to the skin to form a sealant or shield.
U.S. Pat. No. 5,496,296 describes an ostomy appliance having an adhesive gasket, which includes a flexible patch which may be formed of non-woven material and is covered on one side with a first layer of moisture absorbing pressure-sensitive adhesive material surrounding the stomal opening, and a second layer of a soft, easily deformable, extrudable fluid resistant gasket that prevents stomal fluids form contacting the peristomal skin surfaces and the first layer of the adhesive and possibly dissolving that layer and/or disrupting its attachment to skin.